FDA’s 510(k) pathway is getting stronger, Medtech attorney says

The FDA’s less-stringent 510(k) medical device review pathway is no stranger to criticism, but it has at least 1 fan – Hyman, Phelps & McNamara attorney Jeffrey Shapiro.  Shapiro defended the fast-track review pathway, which doesn’t usually require that medical device companies submit to U.S. clinical trials in order to demonstrate safety and efficacy, and he expects that the 510(k) system will “be around for a long time.”

In a presentation prepared for May’s Petrie Flom conference at Harvard Law School’s Petrie-Flom Center for Health Law Policy, Biotechnology & Bioethics, Shapiro shared why he believes the 510(k) pathway is strong and getting stronger all the time.  “Taken as a whole, the 510(k) program has proven adaptable to a wide variety of devices, and has allowed meaningful premarket review while fostering robust technological innovation,” Shapiro wrote in an analysis published in April. “Under the 510(k) program, the device industry has flourished and allowed for increasingly safer and more beneficial device technology, thus providing a practical demonstration that the 510(k) program is working well.”

REFERENCE:  Mass Device; June 4, 2013 by Arezu Sarvestani

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